American Society of Hematology

ASH Makes Recommendations to Implement Clinical Trials Coverage Provision of Health Reform Law

Published on: January 19, 2012

Under the terms of an ASH-supported provision contained in the health reform law, insurers would be prohibited from dropping coverage because an individual chooses to participate in a clinical trial and from denying coverage for routine care that they would otherwise provide just because an individual is enrolled in a clinical trial. The requirement would apply to all insurance products, including those offered in the Federal Employees Health Benefits Program, and to all clinical trials that treat cancer or other life-threatening diseases. States that have enacted laws and policies that go above and beyond the federal standard laid out in the provision would not be preempted.

ASH recently joined several organizations in submitting recommendations to the Centers for Medicare and Medicaid Services (CMS) in advance of the agency's anticipated rulemaking to implement the clinical trials coverage provision. The recommendations made by ASH and the other organizations focused on the following:

  1. Prevention of Delays and Administrative Barriers – Establish explicit safeguards protecting individuals from delays and administrative barriers that undermine access to clinical trials.
  2. Prevention, Detection, and Treatment of Complications – Include explicit safeguards to ensure that the prevention, detection, and treatment of complications arising from clinical trials are covered by group health plans and insurance issuers as routine patient costs.
  3. Geographic Safeguard to Preserve Local Access – Implementing regulations should prevent group health plans and insurance issuers from requiring patients to travel extensive distances to enroll in a clinical trial with an in-network provider.
  4. Clear Coverage Information for Enrollees –Safeguards to ensure patients are informed in an unambiguous manner as to whether or not their group health plan or insurance issuer covers the routine costs associated with participation in clinical trials.
  5. Referral to Specialists – Implementing rules should prevent financial incentives arising from Accountable Care Organizations or other new delivery models from inadvertently creating barriers for patients to participate in clinical trials.
  6. Method for Consumer Reporting – There should be a clear and effective mechanism for reporting concerns relating to the coverage of clinical trials.

ASH will continue to work with physician organizations and patient groups to ensure adequate overage for those enrolled in clinical trials.

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